The Chennai based bulk drug major Orchid Chemicals and Pharmaceuticals, under its research joint venture with the European major Bexel Pharmaceuticals, is currently readying two molecules to be out licensed. The ANDAs, one in the anti-inflammatory segment (oxcolidone) and another in anti-diabetic segment), is at present in the toxicity study stage.
K Raghavendra Rao, managing director, said that the joint venture company would file the ANDAs for these molecules in the US and the approval for the clinical trials would be sought immediately. The company will probably complete the pre clinical studies by the end of the year following which it can look out for prospective takers.
“During 2002-03, Orchid made substantial progress on the joint venture front. The manufacturing joint venture in China, NCPC Orchid Pharmaceuticals is in project execution stage. The drug discovery joint venture in the US, Bexel Pharmaceuticals, has progressed its lead molecule through several studies, which confirmed its efficacy and stability. The applied research joint venture in Europe has established research and manufacturing infrastructure for developing niche peptide and biotechnology products,” Rao added.
“This fiscal year has been a challenging but satisfying year in our overall growth journey. During the past several months, we have been making significant strategic investments in identified growth horizons of bulk actives, formulations and drug discovery. During 2002-03 all the projects that the Company embarked on made substantial progress and many reached completion. The performance in 2002-03 marked by significantly enhanced turnover and profitability, reflects Orchid's ability to manage investment imperatives and market forces of our technology-intensive businesses effectively,” he said.
According to Rao, the bulk actives business posted a record turnover during the last fiscal with superior profitability resulting from capacity generation, product mix optimisation and focused cost reduction initiatives. The formulations business has nearly trebled during the year, achieving a critical scale. With the acquisition of the speciality business of Mano Pharma, our formulations product basket covers an impressive range of acute therapy and chronic therapy products. In drug discovery, we are on the verge of confirming the efficacy of exciting new chemical entities. We hope to further enhance this robust growth performance and revenues during the year 2003-04, he said.
A high point of performance in 2002-03 has been the US FDA certification for the Company's flagship product Cephalexin. Further certifications by the US FDA are planned based on existing and new infrastructure. New US FDA complaint oral and sterile cephalosporin bulk actives facilities earmarked for the regulated markets were commissioned during the last quarter of 2002-2003. The state-of-the-art oral and sterile cephalosporin formulations plant coming up at Irrungattukottai, near Chennai is fast nearing completion. Rao said that d These new facilities would accelerate Orchid's foray into the regulated markets based on US FDA certifications. From 2003-04 onwards, the value inherent in all these new projects will thus be progressively unlocked, leading to step function increases in performance.
During the fiscal under review, Orchid continued to maintain its strong position in the global cephalosporin markets. During the year, Orchid introduced new high-end cephalosporin molecules besides a few niche intermediates. Sale of oral bulk actives accounted for Rs 337 crore and sterile bulk actives brought revenues of Rs 136 crore. The Company sold 800 MT of bulk actives and intermediates, 14% higher than in the last fiscal (701 MT). During the year 2002-03 the company has performed significantly in the formulation as well. The formulations business of the company achieved a major increase in performance, nearly trebling its turnover to Rs 61 crores. Acquisition of Mano Pharma's speciality therapeutic business in the last quarter of this fiscal, contributed in part to the increase.